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Dexlan
Dexlan is a Small molecule drug developed by Chang Gung Memorial Hospital. It is currently in Phase 1 development for Erosive esophagitis, Gastroesophageal reflux disease, Maintenance of Healing Erosive Esophagitis. Also known as: Dexlansoprazole MR.
Dexlan is a medication used in the treatment of Helicobacter Pylori infection. It is part of a concomitant quadruple therapy regimen that includes Dexlan, amoxicillin, and clarithromycin 500mg, as studied in the clinical trial "Anti-Helicobacter Pylori Therapy With Dexlansoprazole MR-Based Concomitant Quadruple Therapy- A Prospective Randomized Trial".
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Dexlan |
|---|---|
| Also known as | Dexlansoprazole MR |
| Sponsor | Chang Gung Memorial Hospital |
| Target | Sterile alpha and TIR motif-containing protein 1, Cytosolic endo-beta-N-acetylglucosaminidase, Potassium-transporting ATPase |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 1 |
Approved indications
- Erosive esophagitis
- Gastroesophageal reflux disease
- Maintenance of Healing Erosive Esophagitis
- Peptic ulcer
Common side effects
Key clinical trials
- Comparing the Efficacy and Impact on Gastrointestinal Microbiota of Reverse Hybrid Therapy and Concomitant Therapy in Helicobacter Pylori Eradication (NA)
- Anti-Helicobacter Pylori Therapy With Dexlansoprazole MR-Based Concomitant Quadruple Therapy- A Prospective Randomized Trial (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dexlan CI brief — competitive landscape report
- Dexlan updates RSS · CI watch RSS
- Chang Gung Memorial Hospital portfolio CI
Frequently asked questions about Dexlan
What is Dexlan?
What is Dexlan used for?
Who makes Dexlan?
Is Dexlan also known as anything else?
What development phase is Dexlan in?
What does Dexlan target?
Related
- Target: All drugs targeting Sterile alpha and TIR motif-containing protein 1, Cytosolic endo-beta-N-acetylglucosaminidase, Potassium-transporting ATPase
- Manufacturer: Chang Gung Memorial Hospital — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Erosive esophagitis
- Indication: Drugs for Gastroesophageal reflux disease
- Indication: Drugs for Maintenance of Healing Erosive Esophagitis
- Also known as: Dexlansoprazole MR
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing